Countries
Countries with insufficient or no manufacturing capacity in the pharmaceutical sector can benefit from participating in
Canada's Access to Medicines Regime. Under the Regime, eligible countries can import less expensive, generic versions of patented products manufactured in Canada. Every product destined for export will first be
reviewed and authorized by Health Canada to ensure that it meets the same safety, effectiveness and quality
requirements as products that are sold in Canada.
The drugs and medical devices available for export to countries in need
are listed on Schedule 1 to Canada's
Patent Act. Schedule 1 can
be amended to ensure that it continues to meet the public health needs of developing countries. Schedule
1 was initially composed of products on the World Health Organization's
Model
List of Essential Medicines that are patented in Canada
but it was expanded at the request of interested stakeholders to include additional products.
Countries eligible to participate in
the Regime include members of the WTO and least-developed or developing
countries that are not members of the WTO. The eligible countries have
been organized into three categories and included on
Schedule 2, Schedule 3 and
Schedule 4 to Canada's Patent
Act.
The requirements for countries participating in the Regime have been kept to a minimum. To participate, a country must
notify the appropriate authority of its intention to import in accordance with the WTO decision and enter into an
agreement with a
Canadian pharmaceutical company.
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